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Cynosure Inc. ($CYNO) reported in a regulatory filing that it has entered into an agreement to settle a class action lawsuit filed by ARcare, Inc. The lawsuit was filed in July 2016 and had accused the firm of violating the federal Telephone Consumer Protection Act (TCPA). It had alleged that the company's fax advertisements violated the TCPA by not providing recipients certain information about how to opt out from receiving them and by sending unsolicited fax advertisements.
The settlement consists of Cynosure paying compensation between $6.5M and $16m, depending on the number of class members that file a valid claim. The company has taken a $7.2M charge in fourth quarter related to the settlement and litigation expenses. The settlement is subject to court approval and the claims process will proceed in H1.

Opko Health Inc. ($OPK) recently announced that launch of a multi-center clinical validation study for the Company’s proprietary Total PSA microfluidic assay cassette running on the Claros® 1 in-office immunoassay analyzer. The pharma company plans to enroll approximately 1,000 patients at 15 sites across the United States. The data will be used to support the Premarket Approval (PMA) application to the FDA for the Total PSA assay and the Claros 1 analyzer. It will also be used for making future FDA submissions of additional assays to be performed on the Claros 1 instrument.
The company stock is currently in weak position, hovering nearly 15 percent above its 52 weeks low. However, Opko stock is likely to make a comeback as the company has ambitious plans for this year. It expects its secondary hyperparathyroidism drug Rayaldee revenue to increase in 2017.

 

• Johnson & Johnson ($JNJ) received 501(k) clearance for DePuy Synthes' VIPER and EXPEDIUM Fenestrated Screw Systems. The device is used in conjunction with the company's CONFIDENCE High Viscosity Spinal Cement. It is designed to restore the integrity of the spinal column in patients with advanced spinal tumors.

• Pfizer ($PFE) announced that Interim data from an 850-subject Phase 2 clinical trial of Clostridium difficile vaccine candidate, Fast Track-tagged PF-06425090, showed significant increases in vaccine-elicited neutralizing antibodies to the two toxins (A & B) produced by C. diff that cause severe diarrhea and colitis. The company now plans to advance PF-06425090 into Phase 3 development in the coming months.
• ZELTIQ Aesthetics Inc. ($ZLTQ) reported receiving FDA approval for its CoolSculpting procedure for the removal of upper arm fat. This is the first non-invasive removal technique to get FDA approval. The company also reported that it will be launching the CoolAdvantage Petite applicator for the CoolSculpting system for optimizing the performance of CoolSculpting in the upper arms.

 
• AstraZeneca ($AZN) received six months of market exclusivity from the FDA for Symbicort (budesonide/formoterol) for use in children ages six months to 12 years with asthma. The agency had reviewed the clinical trial data in the younger population and the company's written request for exclusivity under the provisions of Section 505A of the Food, Drug and Cosmetic Act.
• Tesaro ($TSRO) stock jumped on the speculation that Sanofi ($SNY) may extend a bid for the firm. The company has rolapitant IV for chemotherapy-induced nausea and vomiting and PARP inhibitor niraparib for ovarian and breast cancers as its lead product candidate. It had submitted its U.S. marketing application for niraparib for certain types of epithelial ovarian, fallopian tube or primary peritoneal cancer to the FDA in November 2016.

 
• Celgene Corporation ($CELG) announced its fourth quarter profit at $428.9 million. Its adjusted earnings stood at $1.61 per share, beating consensus estimate of $1.60 per share. The company’s revenue for the quarter stood at $2.98 billion, trailing behind street estimates of $3.01 billion. For the entire year, the company reported profit at $2 billion, or $2.49 per share. Its full year revenue was reported at $11.23 billion.
• Biogen Inc. ($BIIB) reported fourth-quarter net income of $649.2 million. Its adjusted earnings stood at $5.04 per share, topping Wall Street expectations of $4.97 per share. Biogen reported $2.87 billion in the period, trailing behind the expectations of $2.95 billion. The company also provided forecast as it expects full-year earnings in the range of $20.45 to $21.25 per share, with revenue in the range of $11.1 billion to $11.4 billion.

• Trevena Inc ($TRVN) received a Buy rating from Cowen & Co. The price target for the stock has been set at $13 per share.
• Strongbridge Biopharma Plc ($SBBP) received a Buy rating from H.C. Wainwright. The price target for the stock has been set at $18 per share.

Gainers (% price change) Last Trade Change Mkt Cap
NewLink Genetics Corp
NLNK (NASDAQ)
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Clovis Oncology Inc
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Synergy Pharmaceuticals
SGYP (NASDAQ) 5.83 +0.27 (4.86%) 1.05B
Insys Therapeutics Inc
INSY (NASDAQ)
10.14 +0.29 (2.94%) 716.83M
EXACT Sciences Corp.
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Losers (% price change)
McKesson Corporation
MCK (NYSE)
138.55 -12.55 (-8.31%) 31.91B
ABIOMED, Inc.
ABMD (NASDAQ) 106.09 -8.73 (-7.60%) 4.71B
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VAR (NYSE)
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BioTime, Inc.
BTX (NYSEMKT)
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Johnson & Johnson
JNJ (NYSE)
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McKesson Corporation
MCK (NYSE)
138.55 -12.55 (-8.31%) 31.91B
Pfizer Inc.
PFE (NYSE)
31.28 -0.01 (-0.03%) 190.67B
Celgene Corporation
CELG (NASDAQ) 111.53 -2.45 (-2.15%) 87.63B